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EC number: 406-176-9 | CAS number: 79072-96-1 NC-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Short-term toxicity to fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Analytical monitoring:
- not specified
- Vehicle:
- no
- Details on test solutions:
- Details of any method used for dispersal: Homogenised with Ultra turrax for 10 minutes.
- Test organisms (species):
- Oncorhynchus mykiss (previous name: Salmo gairdneri)
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Hardness:
- 213 mg/l CaCO3
- Nominal and measured concentrations:
- Nominal test concentration: 1000 mg/L
No information on measured concentrations available. - Reference substance (positive control):
- not specified
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 1 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- - Any observations (e.g. precipitation) that might cause a difference between measured and nominal values:
The test substance was floating on the surface of the test solutions. - Validity criteria fulfilled:
- not specified
- Conclusions:
- The test material was determined to have a 96hour EC50 >1000 mg/l (nominal concentration) in an acute toxicity study in fish.
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The range-finding study: 30 September 1997 to 4 October 1997. Definitive study: 16 October 1997 to 20 October 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- Water samples were taken from the solvent control and each replicate test vessel at 0, 24 and 96 h for quantitative analysis. Duplicate samples were taken and stored at -20 °C for analysis if necessary.
- Vehicle:
- yes
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: 250 mg of the test material was dissolved in dimethylformamide with the aid of ultrasonication and the volume adjusted to 100 mL to give a 250 mg/ 100 mL solvent stock solution. An aliquot of this stock solution was dispersed in a final volume of 25 mL of dimethylformamide to give a 25 mg/ 25 mL solvent stock solution from which an aliquot was dispersed in 20 L of dechlorinated tap water to prepare 0.10 mg/L test concentration. - Test organisms (species):
- Oncorhynchus mykiss (previous name: Salmo gairdneri)
- Details on test organisms:
- TEST ORGANISM
- Common name: rainbow trout
- Source: Parkwood Trout Farm
- Age at study initiation (mean and range, SD): juvenile
- Length at study end (length definition, mean, range and SD): mean standard length of 4.2 cm (sd= 0.1)
- Weight at study end (mean and range, SD): mean weight of 0.93 g (sd= 0.16)
ACCLIMATION
- Acclimation period: Fish were acclimatised to test conditions from 4 October 1997 to 16 October 1997
- Acclimation conditions (same as test or not): test water used for both the range-finding and definitive studies was the same as theat used to maintain the stock fish.
- Type and amount of food: Commerical trout pellets
- Feeding frequency: food was discontinued 24 h prior to the start of the definitive study. The fish received no food during exposure.
- Health during acclimation (any mortality observed): There was less than 1 % mortality in the 7 d prior to the start of the test - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Post exposure observation period:
- Any mortalities and sub-lethal effects of exposure were recorded at 3, 6, 24, 48, 72 and 96 h after the start of exposure. The criteria of death were taken to be the absence of bothrespiratory movement and response to physical stimulation.
- Hardness:
- 100 mg/L as CaCO3
- Test temperature:
- 14 °C
- pH:
- 7.5- 7.8
- Dissolved oxygen:
- ≥ 9.4 mg O2/L
- Nominal and measured concentrations:
- Range-finding study: nominal test concentrations of 0.010, 0.040 and 0.10 mg/L
Definitive study: nominal test concentration of 0.10 mg/L - Details on test conditions:
- DEFINITIVE STUDY
TEST SYSTEM
- Test vessel: 20 L glass exposure vessels
- Type (delete if not applicable): closed; the test vessels were covered to reduce evaporation
- Aeration: yes; the test vessels were aerated via narrow bore glass tubes
- Renewal rate of test solution (frequency/flow rate): test preparations were renewed daily to ensure that the concentrations of the test material remained near nominal
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 1
- No. of vessels per solvent control (replicates): 1
- Biomass loading rate: 0.47 g bodyweight/L
TEST MEDIUM / WATER PARAMETERS
- Intervals of water quality measurement: The water temperature, pH and dissolved oxygen concentrations were recorded daily throughout the study. The measurements at 0 h, and after each test media renewal at 24, 48 and 72 h, represent those of the freshly prepared test preparations while the measurements taken prior to each test media renewal, and on termination of the study after 96 h represent those of the used or 24-h old test preparations.
OTHER TEST CONDITIONS
- Photoperiod: 16 h light and 8 h darkness with a 20 min dawn and dusk transition period
TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 0.010, 0.040 and 0.10 mg/L
- Results used to determine the conditions for the definitive study: during pre-study solvent solubility work a test concentration of 0.10 mg/L was obtained using a preliminary solution in dimethylformamide. At test concentrations in excess of 0.1 0 mg/L a precipitate of test material was observed (by visual inspection of the prepared test media) indicating 0.10 mg/L to be the maximum limit of water solubility under these test conditions. The control and solvent control groups were maintained under identical conditions but not exposed to the test material. The solvent control group was exposed to 100 µL/L of dimethylformamide.
- Test vessel: 20 L test and control vessel
- Type: closed; each vessel was covered to reduce evaporation
- Observation period: after 24, 48, 72 and 96 h any mortalities or sub lethal effects of exposure were determined by visual inspection of the test fish.
- Pre-study testing: Using a preliminary solution in dimethylformamide a test concentration of 0.10 mg/L was obtained by visual inspection of the test media. Therefore pre-study analysis of a 0.10 mg/L test concentration was carried out to determine the concentration of the test material in the test solution. Water samples were taken at 0 and 24 h for quantitative analysis. - Reference substance (positive control):
- no
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 0.1 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.1 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- Range-finding study
- Mortality: There were no sub-lethal effects of exposure during the range-finding study. The results showed no mortalities at all the test concentrations in the range-finding study.
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: During preliminary solubility work a precipitate of test material was observed (by visual inspection of the prepared test media) at test concentrations in excess of 0.10 mg/L, indicating this to be the maximum limit of water solubility under these test conditions. Based on this information and the results of the range-finding study, a single test concentration, in duplicate, of 0.10 mg/L was selected for the definitive study.
Pre-study testing
Pre-study chemical analysis of a 0.10 mg/L test concentration at 0 and 24 h showed measured concentrations of 105 % and 97 % of nominal respectively therefore confirming that a stable solution/dispersion had been achieved.
Definitive study
- Mortalities: There were no mortalities. There were no sub-lethal effects observed.
- Verification of test concentration: Analysis of the test preparations at 0, 24 and 96 h showed the measured test concentrations to be in excess of the required 80 % of nominal test concentrations and so it was considered justifiable to estimate the LC50 values in terms of the nominal test concentrations only. - Sublethal observations / clinical signs:
The test concentration of 0.10 mg/L was the highest attainable test concentration due to the limited solubility of the test material in water and auxiliary solvent, and having due regard for the amount of auxiliary solvent permitted in the test under the OECD Guidelines. Dimethylformamide was found to give the best testable dispersion of the test material in water. At higher test concentrations there was a marked precipitation of the test material on addition of the solvent stock solution to water.
Verification of test concentrations
Samples
Nominal concentration (mg/L)
Concentration found (mg/L)
Expressed as a % of the nominal concentration
0 hours
Solvent control
<LOQ
-
0.10 R1
0.111
111
0.10 R2
0.114
114
24 hours
Solvent control
<LOQ
-
0.10 R1
0.108
108
0.10 R2
0.0932
93
96 hours
Solvent control
<LOQ
-
0.10 R1
0.120
120
0.10 R2
0.106
106
LOQ= limit of quantitation
R1- R2= Replicates 1- 2
- Validity criteria fulfilled:
- yes
- Conclusions:
- The acute toxicity of the test material to the freshwater fish rainbow trout (Oncorhynchus mykiss) has been investigated and gave a 96-Hour LC50, of greater than 0.10 mg/l. Correspondingly the No Observed Effect Concentration was greater than or equal to 0.10 mg/l.
- Executive summary:
Methods
A study was performed to assess the acute toxicity of the test material to rain bow trout (Oncorhynchus mykiss). The method followed that described in the OECD Guidelines for Testing of Chemicals No 203, "Fish, Acute Toxicity Test" referenced as Method C.1 of Commission Directive 92/69/EEC.
Procedures
Following a preliminary range-finding study and pre-study testing fish were exposed, in 2 groups of 10, to an aqueous dispersion of the test material, at a single concentration of 0.10 mg/L for a period of 96 h under semi-static test conditions. The number of mortalities and any sub-lethal effects of exposure in each test and control vessel were determined 3 and 6 h after the start of exposure and then daily throughout the study until termination after 96 h.
Results
The 96-Hour LC50 for the test material to rainbow trout (Oncorhynchus mykiss), based on nominal test concentrations was > 0.10 mg/L and correspondingly the No Observed Effect Concentration was ≥ to 0.10 mg/L.
The test concentration of 0.10 mg/L was the highest attainable test concentration due to the limited solubility of the test material in water and auxiliary solvent, and having due regard for the amount of auxiliary solvent permitted in the test under the OECD Guidelines.
Analysis of the test solutions at 0, 24 and 96 h showed the measured test concentrations to be in excess of the required 80 % of nominal test concentrations and so the results are based on nominal test concentrations only.
- Endpoint:
- short-term toxicity to fish
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- 1. HYPOTHESIS FOR THE ANALOGUE APPROACH
It is proposed that the structural similarity and properties of the target substance and the structural analogue (sources substance) are sufficiently close for there to be a reasonable expectation of similar effects.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Source chemical:
1,3:2,4-bis-O-(3,4-dimethylbenzylidene)-D-glucitol (EC 413-110-2, CAS 135861-56-2)
Target chemical:
2,6-bis(4-ethylphenyl)perhydro-1,3,5,7-tetraoxanaphth-4-ylethane-1,2-diol (EC 406-176-9, CAS 79072-96-1)
3. ANALOGUE APPROACH JUSTIFICATION
Based on the structural similarity of the source substances and target substance, similarity of physic-chemical properties and similarity in experimental (eco)toxicological test data it is concluded that target substance and the structural analogue (source substance) are sufficiently close for there to be a reasonable expectation of similar effects, for the endpoints where results have been read-across.
4. DATA MATRIX
Please see 'Read-across justification to support the REACH registration of EC 406-176-9' document attached in section 13, - Reason / purpose for cross-reference:
- read-across source
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 0.1 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.1 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- Definitive study
- Mortalities: There were no mortalities. There were no sub-lethal effects observed.
- Verification of test concentration: Analysis of the test preparations at 0, 24 and 96 h showed the measured test concentrations to be in excess of the required 80 % of nominal test concentrations and so it was considered justifiable to estimate the LC50 values in terms of the nominal test concentrations only. - Validity criteria fulfilled:
- yes
- Conclusions:
- The acute toxicity of the test material to the freshwater fish rainbow trout (Oncorhynchus mykiss) has been investigated and gave a 96-Hour LC50, of greater than 0.10 mg/l. Correspondingly the No Observed Effect Concentration was greater than or equal to 0.10 mg/l.
- Executive summary:
Methods
A study was performed to assess the acute toxicity of the test material (structural analogue source substance EC 413-110-2) to rainbow trout (Oncorhynchus mykiss). The method followed that described in the OECD Guidelines for Testing of Chemicals No 203, "Fish, Acute Toxicity Test" referenced as Method C.1 of Commission Directive 92/69/EEC.
Procedures
Following a preliminary range-finding study and pre-study testing fish were exposed, in 2 groups of 10, to an aqueous dispersion of the test material, at a single concentration of 0.10 mg/L for a period of 96 h under semi-static test conditions. The number of mortalities and any sub-lethal effects of exposure in each test and control vessel were determined 3 and 6 h after the start of exposure and then daily throughout the study until termination after 96 h.
Results
The 96-Hour LC50for the test material (EC 413-110-2) to rainbow trout (Oncorhynchus mykiss), based on nominal test concentrations was > 0.10 mg/L and correspondingly the No Observed Effect Concentration was ≥ to 0.10 mg/L.
The test concentration of 0.10 mg/L was the highest attainable test concentration due to the limited solubility of the test material in water and auxiliary solvent, and having due regard for the amount of auxiliary solvent permitted in the test under the OECD Guidelines.
Analysis of the test solutions at 0, 24 and 96 h showed the measured test concentrations to be in excess of the required 80 % of nominal test concentrations and so the results are based on nominal test concentrations only.
Based on these results, it is proposed that the target substance (EC 406-176-9) would not show toxicity up to it's limit of solubility in acute fish toxicity testing.
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 April 1988 and 22 April 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations:
0.10 mg/L in triplicate
- Sampling method:
Samples of test solutions were supplied from the main study at nominal concentrations of 0 and 0.1 µg/mL at time intervals of 0, 24 and 96 hours after preparation.
- Sample storage conditions before analysis:
Water samples were stored deep frozen (- 20°C) prior to analysis. - Vehicle:
- yes
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method of preparation: Preliminary solution in 1% Tween 80 - dimethylsulphoxide.
- Stability of test concentrations: Ensured by daily renewal of test media and verified by chemical analysis at 0, 24 and 96 hours.
0.10 mg/L was the highest concentration that could be prepared due to the limited solubility of the test material in water and having regard to the amount of auxiliary solvent permitted in the test. - Test organisms (species):
- Oncorhynchus mykiss (previous name: Salmo gairdneri)
- Details on test organisms:
- TEST ORGANISM
- Common name: Rainbow Trout
- Strain: Salmo gairdneri
- Source: Parkwood Trout Farm, Kent, UK
- Length at study initiation (length definition, mean, range and SD): Mean standard length: 4.7 cm (SD = 0.1 cm)
- Weight at study initiation (mean and range, SD): Mean weight: 1.41 g (SD = 0.18 g)
- Feeding during test: no
- Food type: Commercial trout pellets
- Amount: Not stated but discontinued 24 hours prior to test.
- Frequency: Daily.
ACCLIMATION
- Acclimation period: Acclimatised to test conditions from 11 - 18 April 1988.
- Type and amount of food: Commercial trout pellets
- Feeding frequency: Daily
-Temperature: 14 ± 1°C
- Dissolved oxygen: >9.8 mgO2/l
- Health during acclimation (any mortality observed):
Mortalities: < 1% - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Post exposure observation period:
- Any mortalities and sub-lethal effects of exposure were recorded at 3, 6, 24, 48, 72 and 96 hours after the start of exposure. The criteria of death were taken to be absence of (i) respiratory movement and (ii) response to physical stimulation.
- Hardness:
- Total hardness of approximately 350 mg/L as CaCO3.
- Test temperature:
- 14 ± 1°C
- pH:
- pH range of 8.2 - 8.4
- Dissolved oxygen:
- Dissolved oxygen range of 9.5 - 9.9
- Salinity:
- Not applicable as this was a freshwater study.
- Nominal and measured concentrations:
- Nominal concentraiton: 0.10 mg/L
- Details on test conditions:
- TEST SYSTEM
- Test vessel: Glass aquaria.
- Material, size, headspace, fill volume: 40 L
- Aeration: Yes, via narrow bore glass tubes
- Renewal rate of test solution (frequency/flow rate): daily
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 3
- No. of vessels per vehicle control (replicates): 1
- Biomass loading rate: 0.35 g bodyweight/L
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Laboratory tap water, dechloronated by the addition of sodium thiosulphate. Total hardness = 350 mg/L as Ca CO3. This value is slightly higher than the recommended range but is not considered to have had any significant effects on the results of the test.
OTHER TEST CONDITIONS
- Photoperiod: 16 hours light, 8 hours dark
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Absence of (i) respiratory movement and (iii) response to physical stimulation was assessed at intervals of 0, 3, 6, 24, 48, 72 and 96 hours.
TEST CONCENTRATIONS
0.10 mg/L was the highest concentration that could be prepared due to the limited solubility of the test material in water and having regard to the amount of auxiliary solvent permitted in the test. - Reference substance (positive control):
- no
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 0.1 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- There were no mortalities or other adverse reactions to exposure in 30 fish exposed to a test concentration of 0.10 mg/l for 96 hours.
Highest test concentration resulting in 0% mortalitiy: >0.10 mg/l
Lowest test concentration resulting in 100% mortality: >0.10 mg/l - Results with reference substance (positive control):
- Not applicable.
- Validity criteria fulfilled:
- yes
- Conclusions:
- There were no mortalities or other adverse reactions to exposure in 30 fish exposed to a test concentration of 0.10 mg/L Gel-All MD for 96 hours.
Highest test concentration resulting in 0% mortality > 0.10 mg/L
Lowest test concentration resulting in 100% mortality > 0.10 mg/L - Executive summary:
Gel-All MD was assessed for Acute toxicity (96 h LC50) toRainbow Trout (Salmo gairdneri).
The test was conducted using semi-static test conditions according to OECD Guideline No. 203 and EEC Directive 67/548, Annex V C.1 as published in 84/449/EEC.
A single test concentration of 0.10 mg/l (in triplicate) was tested.
Measured concentrations of substance in analysed samples ranged from 169 to 75% nominal.
There were no mortalities or other adverse reactions to exposure in 30 fish exposed to a test concentration of 0.10 mg/L Gel-All MD for 96 hours
3, 6, 24, 48, 72 and 96 hr LC50: >0.10 mg/l
0.10 mg/L was the highest test concentration that could be prepared due to the limited solubility of the test material in water and having regards to the amount of auxiliary solvent permitted in the test.
- Endpoint:
- short-term toxicity to fish
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- 1. HYPOTHESIS FOR THE ANALOGUE APPROACH
It is proposed that the structural similarity and properties of the target substance and the structural analogue (sources substance) are sufficiently close for there to be a reasonable expectation of similar effects.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Source chemical:
1-(2,6-bis(4-tolyl)-1,3-dioxano(5,4-d)-1,3-dioxan-4-yl)ethane-1,2-diol (EC 402-950-5, CAS 87826-41-3)
Target chemical:
2,6-bis(4-ethylphenyl)perhydro-1,3,5,7-tetraoxanaphth-4-ylethane-1,2-diol (EC 406-176-9, CAS 79072-96-1)
3. ANALOGUE APPROACH JUSTIFICATION
Based on the structural similarity of the source substances and target substance, similarity of physic-chemical properties and similarity in experimental (eco)toxicological test data it is concluded that target substance and the structural analogue (source substance) are sufficiently close for there to be a reasonable expectation of similar effects, for the endpoints where results have been read-across.
4. DATA MATRIX
Please see 'Read-across justification to support the REACH registration of EC 406-176-9' document attached in section 13. - Reason / purpose for cross-reference:
- read-across source
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 0.1 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- There were no mortalities or other adverse reactions to exposure in 30 fish exposed to a test concentration of 0.10 mg/l for 96 hours.
Highest test concentration resulting in 0% mortalitiy: >0.10 mg/l
Lowest test concentration resulting in 100% mortality: >0.10 mg/l - Validity criteria fulfilled:
- yes
- Conclusions:
- There were no mortalities or other adverse reactions to exposure in 30 fish exposed to a test concentration of 0.10 mg/L Gel-All MD for 96 hours.
Highest test concentration resulting in 0% mortality > 0.10 mg/L
Lowest test concentration resulting in 100% mortality > 0.10 mg/L - Executive summary:
Gel-All MD (structural analgoue source substance EC 402-950-5) was assessed for Acute toxicity (96 h LC50) to Rainbow Trout (Salmo gairdneri).
The test was conducted using semi-static test conditions according to OECD Guideline No. 203 and EEC Directive 67/548, Annex V C.1 as published in 84/449/EEC.
A single test concentration of 0.10 mg/l (in triplicate) was tested. Measured concentrations of substance in analysed samples ranged from 169 to 75% nominal.
There were no mortalities or other adverse reactions to exposure in 30 fish exposed to a test concentration of 0.10 mg/L Gel-All MD for 96 hours
3, 6, 24, 48, 72 and 96 hr LC50: >0.10 mg/l
0.10 mg/L was the highest test concentration that could be prepared due to the limited solubility of the test material in water and having regards to the amount of auxiliary solvent permitted in the test.
Based on these results, it is proposed that the target substance (EC 406-176-9) would not show toxicity up to it's limit of solubility in acute fish toxicity testing.
Referenceopen allclose all
Description of key information
The acute toxicity to fish of the substance (EC 406-176-9) has been assessed by OECD 203 study on substance itself and supported by reading across the results of studies conducted on two structurally similar analogue substances.
OECD 203 study on EC 406-176-9:
The test material was determined to have a 96 hour EC50 >1000 mg/l (nominal concentration) in an acute toxicity study in fish.
No details on measured concentration are available but based on the low water solubility of substance the measured concentration would be expected to be significantly lower. This is supported by the results on structurally similar analogue substances.
Source Substance; 1,3:2,4-bis-O-(3,4-dimethylbenzylidene)-D-glucitol (EC-413 -110 -2):
A study was performed to assess the acute toxicity of the test material (EC 413-110-2) to rainbow trout (Oncorhynchus mykiss).
Procedures
Following a preliminary range-finding study and pre-study testing fish were exposed, in 2 groups of 10, to an aqueous dispersion of the test material, at a single concentration of 0.10 mg/L for a period of 96 h under semi-static test conditions. The number of mortalities and any sub-lethal effects of exposure in each test and control vessel were determined 3 and 6 h after the start of exposure and then daily throughout the study until termination after 96 h.
Results
The 96-Hour LC50for the test material (EC 413-110-2) to rainbow trout (Oncorhynchus mykiss), based on nominal test concentrations was > 0.10 mg/L and correspondingly the No Observed Effect Concentration was ≥ to 0.10 mg/L.
The test concentration of 0.10 mg/L was the highest attainable test concentration due to the limited solubility of the test material in water and auxiliary solvent, and having due regard for the amount of auxiliary solvent permitted in the test under the OECD Guidelines.
Analysis of the test solutions at 0, 24 and 96 h showed the measured test concentrations to be in excess of the required 80 % of nominal test concentrations and so the results are based on nominal test concentrations only.
Source Substance; 1-(2,6-bis(4-tolyl)-1,3-dioxano(5,4-d)-1,3-dioxan-4-yl)ethane-1,2-diol (EC 402-950-5):
Gel-All MD (EC 402-950-5) was assessed for Acute toxicity (96 h LC50) to Rainbow Trout (Salmo gairdneri).
The test was conducted using semi-static test conditions.
A single test concentration of 0.10 mg/l (in triplicate) was tested. Measured concentrations of substance in analysed samples ranged from 169 to 75% nominal.
There were no mortalities or other adverse reactions to exposure in 30 fish exposed to a test concentration of 0.10 mg/L Gel-All MD for 96 hours
3, 6, 24, 48, 72 and 96 hr LC50: >0.10 mg/l
0.10 mg/L was the highest test concentration that could be prepared due to the limited solubility of the test material in water and having regards to the amount of auxiliary solvent permitted in the test.
Key value for chemical safety assessment
Additional information
Based on study data on the substance itself and on two read-across substance studies it is considered that the substance does show toxicity up to its limit of solubility in acute fish toxicity testing.
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